To ensure their effectiveness and safety, food for special medical purposes (FSMPs)FSMPs are governed by regulations and are required to adhere to specific standards. The FSMP industry is regulated by various national and international bodies, such as the European Food Safety Authority (EFSA) and the U.S. Food and Drug Administration (FDA), which set standards for the safety, quality, and efficacy of FSMP products ^[1][2][3][4][1,2,3,4].

FSMPs are defined according to Article 2(2)(g) of Regulation 609/2013 [5] as food specially processed or formulated for the dietary management of patients, including infants, to be used under medical supervision. It is intended for exclusive or partial feeding of patients with a limited capacity to take, digest, absorb, metabolise, or excrete ordinary food or certain nutrients.

For example, in Romania, Regulation 128/2018 updated Regulation 609/2013 mentioned above (named within most of the documents as “FSG Regulation”), and the food notification procedure for special medical purposes (FSMP) was set by Order of the Ministry of Health nr.820/2019 [6]. Furthermore, specific standards that apply to FSMP are also outlined within Codex Alimentarius by the World Health Organisation. At the same time, the Commission clarified the distinction between FSMP and food supplement products within a dedicated document ^[1][4][1,4].

2. Understanding FSMP Composition and Labelling Requirements

FSMPs are divided into three groups [1]: (a) nutritionally complete foods with a standard nutrient formulation, (b) nutritionally complete foods with a nutrient-adapted formulation unique to a disease, disorder, or medical condition, and (c) nutritionally incomplete foods with either a standard formulation or a nutrient-adapted formulation unique to a disease, disorder, or medical condition. The first two categories can serve as a patient’s only source of nutrition, whereas the third can only increase intake to supplement other sources of nutrients. The FSG Regulation and Codex Alimentarius both clearly define the composition of products, which are defined as FSMP that must contain specific nutrients from the List (vitamins, minerals, amino acids, carnitine-taurine, nucleotides, and choline-inositol) or meet specific requirements (meet food standards, provide scientific support regarding the contribution of ingredients to satisfying nutritional needs and to comply with conditions related to pesticides) ^[2][4][5][2,4,5]. Some writers believe that FSMPs intended for oncology patients may not be adequate for some critical elements, such as Zn, Cu, Se, Fe, or Mn, despite the regulatory standards regarding the composition of FSMPs, implying that the formulations are based on commonly accepted scientific facts [7]. In addition, similar studies have indicated that sample determination for Se, Zn, K, Mg, and vitamin C differ from (E.U.) 2016/128 requirements for enteral tube feed formulae, raising questions about the bioavailability of synthetic vitamins and minerals in comparison to those from natural sources [8]. Products classified as FSMP should be usable by humans and provide nutritional support, while a different classification is being developed by an interdisciplinary group in the German industry ^[5][9][5,9]. Regulatory bodies have highlighted the importance of accurately labelling FSMP products. Labelling should provide information regarding energy value, protein content, vitamins and minerals, osmolarity and/or acid-base balance, and the origin and nature of proteins. Manufacturers should disclose the nature of the product, its purpose, and specific usage instructions in sufficient detail. References to usage guidelines should be made, such as use only under medical supervision and not suited for parenteral use. It is important to provide educational materials and resources to healthcare professionals ^[1][4][10][1,4,10].

3. Examining the Use of FSMPs in Cancer Care: Treatment Benefits and Associated Costs

Stomatitis and oral mucositis are common in oncology patients receiving chemotherapy or radiation therapy, which can have a negative impact on their quality of life. Nutrition can help reduce stress and oncology treatment expenses. Medical costs for patients receiving radiotherapy and developing mucositis or pharyngitis during the treatment are much greater than for those without such conditions, according to a study on patients with head and neck cancer (HNC) and non-small cell lung cancer (USD39,313 vs. USD20,798) [11]. Another study on HNC patients receiving radiotherapy found that 91 percent of patients experienced oral mucositis, and 66 percent of those cases were severe (>Grade 3). Depending on the severity, oral mucositis was associated with increased expenses of USD1700–USD6000 [12]. In addition, the side effects of cancer treatment, such as nausea, vomiting, oral mucositis, and exhaustion, create numerous logistical difficulties and significantly strain the patient and the healthcare system, especially when cancer is treated as a chronic condition [13]. According to a different study, oral or/and G.I. mucositis occurred in 51% of chemotherapy-treated cancer patients with solid tumours or lymphoma. If a patient has oral mucositis or both, G.I. and oral mucositis, the projected cost of chemotherapy for each cycle is 1.6 times higher and 2.3 times higher, respectively. For patients receiving a haematopoietic cell transplant, an additional point in the peak mucositis score resulted in an additional USD25,000 in hospital expenses [14]. In treating several cancers, surgery, chemotherapy (including immunotherapy or target therapy), and radiotherapy may be employed, and the expenditures involved with all these efforts are substantial [15]. Early nutrition support and prevention of radiochemotherapy-related side effects for cancer patients can reduce weight loss, fewer breaks, delays, and hospitalisations, and increase treatment completion ^{[14][16][17][18]}[14,16,17,18]. National healthcare systems reimburse FSMP products in several countries. The E.U. allows for regional or provincial variations in granting FSMP reimbursement. France, Germany, Italy, Spain, and the UK are some nations that reimburse FSMPs. Additionally, France and Brazil are the countries that have a formal HTA process for medical nutrition [19]. However, FSMP type and content may affect reimbursement criteria and procedures. It is critical to remember that depending on the country and the patient’s medical condition, different restrictions may apply for FSMP product reimbursement ^[19][20][21][19,20,21]. Chinese researchers and authorities place a high value on FSMP and health technology assessment (HTA—a systematic evaluation of healthcare interventions to determine their safety, effectiveness, and cost-effectiveness) for products under this category. Several papers have been written about creating rules, clinical trial prerequisites, and HTA evaluation standards ^[22][23][24][22,23,24].

4. Exploring the Landscape of FSMP Products: Market Size, Key Brands, Players, and Unique Marketing Factors

The worldwide FSMP market is estimated to be worth USD11.2 billion in 2019 or USD13.48 billion in 2021, and could reach USD19.67 billion in 2028 or USD19.41 billion in 2030. The key drivers of growth are increased awareness of the benefits of this category of products, increased prevalence of chronic diseases, increased demand for older adults, proliferation of new private label manufacturers, and expansion of new distribution channels. More than 65 percent of the market share is held by the top 10 companies, including Nestle, Danone (Nutricia), Abbott, Bayer, Mead-Johnson, Ajinomoto, Fresenius-Kabi, Lenus Pharma, GFI-Gruppo Farmaimpresa, Galen Limited, BOSSD, and Leskon & EnterNutr ^[25][26][27][25,26,27]. The regulation stipulates that using FSMPs requires medical supervision, and healthcare professionals (HCPs) can help patients with FSMPs. Without the limits typically imposed on communication to the general public, HCPs must receive complete information regarding the product composition, clinical justification, appropriate usage, preparation, and intended target group ^[5][20][5,20]. Pharmacies and pharmacists must investigate the legal responsibilities for dispensing FSMPs, as there are no formal prescription requirements to trace the recommendation process [28]. Public outreach efforts should be limited to labelling, educational content, and using digital techniques like Search Engine Optimisation (SEO) and Search Engine Marketing (SEM). Digitalisation of healthcare systems is a fact that will significantly impact future issues. Digital tools can help monitor, assess, and manage food safety hazards and offer consumers and health professionals information and transparency. Additionally, digital technologies can assist in customising FSMPs based on an individual’s needs [29].